Raymond R Tjandrawinata, Arini Setiawati, Dwi Nofiarny, Liana W Susanto, Effi Setiawati
{"title":"非甾体抗炎药依托考昔的药代动力学等效性研究。","authors":"Raymond R Tjandrawinata, Arini Setiawati, Dwi Nofiarny, Liana W Susanto, Effi Setiawati","doi":"10.2147/CPAA.S161024","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>The current study aimed to evaluate whether a generic product of etoricoxib 120 mg film-coated tablet (the test drug) was bioequivalent to the reference product (Arcoxia® film-coated tablet 120 mg).</p><p><strong>Methods: </strong>This was a randomized, open-label, two-sequence, crossover study under fasting condition, with a 14-day washout period, involving 26 healthy adult male and female subjects. Blood samples were taken and analyzed for plasma concentrations of etoricoxib (Chemical Abstracts Service [CAS] 202409-33-4) using a high-pressure liquid chromatography-ultraviolet detector (HPLC-UV) system capable of measuring etoricoxib concentrations ranging from 5.00 to 5002.90 ng/mL, with the lowest limit of quantitation of 5.00 ng/mL. A noncompartmental method was used to determine the pharmacokinetic parameters of a single-dose administration of the drug, including the area under plasma concentration-time curve from time zero to the time of last observed concentration (AUC<sub>0-</sub><i><sub>t</sub></i> ), the area under plasma concentration-time curve from time zero to infinity (AUC<sub>0-∞</sub>), the maximum plasma concentration (<i>C</i><sub>max</sub>), the time to reach the maximum plasma concentration (<i>t</i><sub>max</sub>), and the terminal half-life (<i>t</i><sub>½</sub>).</p><p><strong>Results: </strong>After a single-dose administration of etoricoxib 120 mg film-coated tablet, the mean (SD) values for the AUC<sub>0-72h</sub> and <i>C</i><sub>max</sub> of the test drug were 45913.42 (13142.19) ng·h/mL and 3155.93 (752.81) ng/mL, respectively; the values for the reference drug were 44577.20 (13541.85) ng·h/mL and 2915.13 (772.81) ng/mL, respectively. The geometric mean ratios (90% CIs) of the test drug/reference drug were 103.40% (98.70%-108.32%) for AUC<sub>0-72h</sub> and 109.26% (100.18%-119.18%) for <i>C</i><sub>max</sub>. No clinically significant differences in <i>t</i><sub>max</sub> and <i>t</i><sub>½</sub>values were found between the test drug and the reference drug. No adverse events were experienced by the subjects during this study.</p><p><strong>Conclusion: </strong>The present study demonstrated that the evaluated generic etoricoxib 120 mg film-coated tablets were bioequivalent to the reference drug.</p>","PeriodicalId":10406,"journal":{"name":"Clinical Pharmacology : Advances and Applications","volume":"10 ","pages":"43-51"},"PeriodicalIF":3.1000,"publicationDate":"2018-04-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/65/22/cpaa-10-043.PMC5896653.pdf","citationCount":"0","resultStr":"{\"title\":\"Pharmacokinetic equivalence study of nonsteroidal anti-inflammatory drug etoricoxib.\",\"authors\":\"Raymond R Tjandrawinata, Arini Setiawati, Dwi Nofiarny, Liana W Susanto, Effi Setiawati\",\"doi\":\"10.2147/CPAA.S161024\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>The current study aimed to evaluate whether a generic product of etoricoxib 120 mg film-coated tablet (the test drug) was bioequivalent to the reference product (Arcoxia® film-coated tablet 120 mg).</p><p><strong>Methods: </strong>This was a randomized, open-label, two-sequence, crossover study under fasting condition, with a 14-day washout period, involving 26 healthy adult male and female subjects. Blood samples were taken and analyzed for plasma concentrations of etoricoxib (Chemical Abstracts Service [CAS] 202409-33-4) using a high-pressure liquid chromatography-ultraviolet detector (HPLC-UV) system capable of measuring etoricoxib concentrations ranging from 5.00 to 5002.90 ng/mL, with the lowest limit of quantitation of 5.00 ng/mL. A noncompartmental method was used to determine the pharmacokinetic parameters of a single-dose administration of the drug, including the area under plasma concentration-time curve from time zero to the time of last observed concentration (AUC<sub>0-</sub><i><sub>t</sub></i> ), the area under plasma concentration-time curve from time zero to infinity (AUC<sub>0-∞</sub>), the maximum plasma concentration (<i>C</i><sub>max</sub>), the time to reach the maximum plasma concentration (<i>t</i><sub>max</sub>), and the terminal half-life (<i>t</i><sub>½</sub>).</p><p><strong>Results: </strong>After a single-dose administration of etoricoxib 120 mg film-coated tablet, the mean (SD) values for the AUC<sub>0-72h</sub> and <i>C</i><sub>max</sub> of the test drug were 45913.42 (13142.19) ng·h/mL and 3155.93 (752.81) ng/mL, respectively; the values for the reference drug were 44577.20 (13541.85) ng·h/mL and 2915.13 (772.81) ng/mL, respectively. The geometric mean ratios (90% CIs) of the test drug/reference drug were 103.40% (98.70%-108.32%) for AUC<sub>0-72h</sub> and 109.26% (100.18%-119.18%) for <i>C</i><sub>max</sub>. No clinically significant differences in <i>t</i><sub>max</sub> and <i>t</i><sub>½</sub>values were found between the test drug and the reference drug. No adverse events were experienced by the subjects during this study.</p><p><strong>Conclusion: </strong>The present study demonstrated that the evaluated generic etoricoxib 120 mg film-coated tablets were bioequivalent to the reference drug.</p>\",\"PeriodicalId\":10406,\"journal\":{\"name\":\"Clinical Pharmacology : Advances and Applications\",\"volume\":\"10 \",\"pages\":\"43-51\"},\"PeriodicalIF\":3.1000,\"publicationDate\":\"2018-04-06\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/65/22/cpaa-10-043.PMC5896653.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical Pharmacology : Advances and Applications\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.2147/CPAA.S161024\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2018/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q2\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Pharmacology : Advances and Applications","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.2147/CPAA.S161024","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2018/1/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
Pharmacokinetic equivalence study of nonsteroidal anti-inflammatory drug etoricoxib.
Purpose: The current study aimed to evaluate whether a generic product of etoricoxib 120 mg film-coated tablet (the test drug) was bioequivalent to the reference product (Arcoxia® film-coated tablet 120 mg).
Methods: This was a randomized, open-label, two-sequence, crossover study under fasting condition, with a 14-day washout period, involving 26 healthy adult male and female subjects. Blood samples were taken and analyzed for plasma concentrations of etoricoxib (Chemical Abstracts Service [CAS] 202409-33-4) using a high-pressure liquid chromatography-ultraviolet detector (HPLC-UV) system capable of measuring etoricoxib concentrations ranging from 5.00 to 5002.90 ng/mL, with the lowest limit of quantitation of 5.00 ng/mL. A noncompartmental method was used to determine the pharmacokinetic parameters of a single-dose administration of the drug, including the area under plasma concentration-time curve from time zero to the time of last observed concentration (AUC0-t ), the area under plasma concentration-time curve from time zero to infinity (AUC0-∞), the maximum plasma concentration (Cmax), the time to reach the maximum plasma concentration (tmax), and the terminal half-life (t½).
Results: After a single-dose administration of etoricoxib 120 mg film-coated tablet, the mean (SD) values for the AUC0-72h and Cmax of the test drug were 45913.42 (13142.19) ng·h/mL and 3155.93 (752.81) ng/mL, respectively; the values for the reference drug were 44577.20 (13541.85) ng·h/mL and 2915.13 (772.81) ng/mL, respectively. The geometric mean ratios (90% CIs) of the test drug/reference drug were 103.40% (98.70%-108.32%) for AUC0-72h and 109.26% (100.18%-119.18%) for Cmax. No clinically significant differences in tmax and t½values were found between the test drug and the reference drug. No adverse events were experienced by the subjects during this study.
Conclusion: The present study demonstrated that the evaluated generic etoricoxib 120 mg film-coated tablets were bioequivalent to the reference drug.
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